Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005189
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Carotid Atherosclerosis Follow-up Study
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether the degree of carotid artery atherosclerosis as measured by B-mode ultrasound predicts the development of myocardial infarction stroke and all-cause mortality in patients with angiographically defined coronary status Also to quantify the rate of progression of carotid artery disease and to evaluate the risk factors associated with progression of carotid atherosclerosis
Detailed Description:
BACKGROUND
Although angiographic evidence of coronary atherosclerosis is one of the best predictors of clinical events non-invasive imaging of this arterial bed is not yet possible The availability of non-invasive methods for imaging the carotid arteries and the intra-individual similarity of extent of disease in the coronary and carotid arteries provides rationale for this study that assesses the usefulness of B-mode ultrascan evaluation of extracranial carotid artery atherosclerosis as an independent predictor of clinical sequelae such as fatal and non-fatal myocardial infarction and stroke
DESIGN NARRATIVE
Pilot data from an ongoing case-comparison study of risk factors for coronary and carotid atherosclerosis as defined by angiography and B-mode ultrasound provided a background for this project Patients from the pilot study were used in this study Beginning in 1986 traditional risk factors such as lipids lipoproteins blood pressure diabetes and smoking were measured as were non-traditional risk factors such as apolipoproteins and genetic markers The cohort was followed for 35 to 85 years for incidence of clinical events Multivariate techniques were used to relate disease or risk factor status to all-cause mortality fatal and non-fatal myocardial infarction and fatal and non-fatal stroke The same subjects were re-evaluated periodically by B-mode for extent of carotid atherosclerosis A fifty percent random sample of patients positive for both cerebrovascular disease and coronary artery disease and a fifty percent random sample of patients negative for both cerebrovascular disease and coronary artery disease had repeat B-mode measurements at 25 years All patients surviving at the end of five years had repeat B-mode scans
The study was renewed in 1996 through April 1999 to conduct a longitudinal study testing the following hypotheses 1 Incidence of cardiovascular events bypass surgery angioplasty fatal and non-fatal myocardial infarction and stroke and endarterectomy in men and women with extensive carotid wall thickening CWT at baseline exceeds that of those with less extensive baseline carotid wall thickening the relation of carotid wall thickening to outcome is independent of coronary artery disease andor coronary artery disease risk factors and 2 carotid wall thickening progresses more rapidly in males and females with coronary artery disease andor coronary artery disease risk factors than in coronary artery diseaserisk factor free controls
The investigators intend to 1 follow-up a cohort of 670 individuals with defined coronary anatomy extent of carotid wall thickening and coronary artery disease risk factors over 5-10 years for fatal and non-fatal cardiovascular events Coronary artery disease carotid wall thickening and coronary artery disease risk factor status at accession will be related to outcome and 2 In a separate new cohort of 280 volunteers with and without coronary artery disease they will evaluate carotid wall thickening yearly for three years and use multivariable analysis to relate accession status to progression rate Availability of a unique sample of patients largely already characterized for coronary status at angiography coronary artery disease risk factors and carotid wall thickening and development of B-mode methods for quantifying carotid wall thickening and biostatistical approaches for quantifying progression of carotid wall thickening over a short time span three years provide opportunity for this project Recent pilot data support its feasibility
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Although angiographic evidence of coronary atherosclerosis is one of the best predictors of clinical events non-invasive imaging of this arterial bed is not yet possible The availability of non-invasive methods for imaging the carotid arteries and the intra-individual similarity of extent of disease in the coronary and carotid arteries provides rationale for this study that assesses the usefulness of B-mode ultrascan evaluation of extracranial carotid artery atherosclerosis as an independent predictor of clinical sequelae such as fatal and non-fatal myocardial infarction and stroke
DESIGN NARRATIVE
Pilot data from an ongoing case-comparison study of risk factors for coronary and carotid atherosclerosis as defined by angiography and B-mode ultrasound provided a background for this project Patients from the pilot study were used in this study Beginning in 1986 traditional risk factors such as lipids lipoproteins blood pressure diabetes and smoking were measured as were non-traditional risk factors such as apolipoproteins and genetic markers The cohort was followed for 35 to 85 years for incidence of clinical events Multivariate techniques were used to relate disease or risk factor status to all-cause mortality fatal and non-fatal myocardial infarction and fatal and non-fatal stroke The same subjects were re-evaluated periodically by B-mode for extent of carotid atherosclerosis A fifty percent random sample of patients positive for both cerebrovascular disease and coronary artery disease and a fifty percent random sample of patients negative for both cerebrovascular disease and coronary artery disease had repeat B-mode measurements at 25 years All patients surviving at the end of five years had repeat B-mode scans
The study was renewed in 1996 through April 1999 to conduct a longitudinal study testing the following hypotheses 1 Incidence of cardiovascular events bypass surgery angioplasty fatal and non-fatal myocardial infarction and stroke and endarterectomy in men and women with extensive carotid wall thickening CWT at baseline exceeds that of those with less extensive baseline carotid wall thickening the relation of carotid wall thickening to outcome is independent of coronary artery disease andor coronary artery disease risk factors and 2 carotid wall thickening progresses more rapidly in males and females with coronary artery disease andor coronary artery disease risk factors than in coronary artery diseaserisk factor free controls
The investigators intend to 1 follow-up a cohort of 670 individuals with defined coronary anatomy extent of carotid wall thickening and coronary artery disease risk factors over 5-10 years for fatal and non-fatal cardiovascular events Coronary artery disease carotid wall thickening and coronary artery disease risk factor status at accession will be related to outcome and 2 In a separate new cohort of 280 volunteers with and without coronary artery disease they will evaluate carotid wall thickening yearly for three years and use multivariable analysis to relate accession status to progression rate Availability of a unique sample of patients largely already characterized for coronary status at angiography coronary artery disease risk factors and carotid wall thickening and development of B-mode methods for quantifying carotid wall thickening and biostatistical approaches for quantifying progression of carotid wall thickening over a short time span three years provide opportunity for this project Recent pilot data support its feasibility
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL035333 | NIH | None | httpsreporternihgovquickSearchR01HL035333 |